Drug product
Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
D-1080-2015
Product summary
- Firm
- Apotex Inc.
- Event
- Event 71046
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6,467 bottles/ blister cartons
- Official record key
drug-enforcement:D-1080-2015
Official wording
Reason: Subpotent drug
Code information: Lot #: a) KY2389, Exp 05/16; b) KY2388, Exp 05/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent